Job Title – Clinical Affairs Consultant
Job Location – Remote
Length – Contract (7 Months+)
Description -
The Clinical Affairs Consultant III role will be responsible for performing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs), associated documents, templates, and processes in compliance with MEDDEV 2.7.1 Rev. 4 and the European Medical Device Regulation (EU MDR). If a candidate has this specific experience, they will likely be a fit for the role as the required experience will already be in place based on having done this type of work before.
The candidate should have excellent written and verbal communication skills, possess a strong sense of responsibility and urgency, and have a minimum of 5 years direct experience performing Clinical Evaluations and writing CERs compliant with MEDDEV 2.7.1. Familiarity with EU MDR requirements for CERs is a plus.
This position requires the ability to interpret data from scientific literature and clinical studies and summarize the results and in a clear, concise, and scientifically accurate manner in the CER.
Best,
Kushal Shah
APN Software Service INC
609-357-9180 (Direct)